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  6. eMDR – Electronic Medical Device Reporting
  7. eMDR Help and FAQs
  1. eMDR – Electronic Medical Device Reporting

eMDR Help and FAQs

Users will receive three acknowledgements (Ack1, Ack2, and Ack3) during the submission process. Multiple helpdesks are available to assist eMDR submitters with common issues related to these Acks.

Helpdesk Name Email Common Issues Handled
ESG Helpdesk [email protected] Ack1 or Ack2 not received
CDRH Electronic Submissions Helpdesk [email protected] Ack3 not received
eMDR Helpdesk [email protected] Ack3 received with failure

Troubleshooting

Reporters who experience technical issues other than missing acknowledgements should review this troubleshooting section and check the Frequently Asked Questions below before emailing the eMDR Helpdesk ([email protected]) to request support.

Issue Resolution

I am experiencing an error in WebTrader

Email the ESG HelpDesk at [email protected] and request support

I am experiencing an error in eSubmitter

Email the eSubmitter Helpdesk at [email protected] and request support

Ack3 says my report failed due to a "duplicate report" error

This error means that eMDR has already accepted a report with this report number. If this is a supplemental report, verify that it is marked as a follow-up and has the correct follow-up number. If you are submitting to pre-production, note that pre-production may contain reports received in production or from paper submissions. Pre-production eMDR submissions should always have report numbers that have never been used before on any MDR.

I am a high-volume submitter and I get the "duplicate report" error on the first submission of a report

Email the CDRH Electronic Submissions Helpdesk at [email protected] and request that they look up the core ID for the report with the report number in question. Your AS2 system may have sent the same report twice, or there could be some other technical issue.

Ack3 says my report failed due to having an invalid report number

This error means that the report number you provided was not valid. Every report (even reports to the pre-production system) must include a current and valid FEI or CFN number in the first part of the report number. The pre-production eMDR system will also reject reports with very high years (ex. 9000). The sequence number in the final part of the report number should always have five digits, and the first report of each year should have sequence number 00001.
Ack3 says that my report failed due to an invalid adverse event code. This error means that one of the codes you provided in F10 or H6 was not valid. Please remove the offending code, choose a new code using the FDA MDR Adverse Event Codes website, and resubmit. If you are using eSubmitter, make sure that you have the latest version using the Help > About dialog.
Ack3 says my report failed due to having an invalid state code. This error means the state code you entered in one of the address fields was not a valid U.S. state code. If you are entering a non-U.S. address, please include the state/province in the City field.

Frequently Asked Questions

Question Answer
How do I sign up for ESG or eMDR? Go to the eMDR Enrollment site to sign up.
How long does it take to receive a new ESG account and enroll in eMDR? Receiving a new ESG account and enrolling as a low-volume eMDR submitter takes approximately one to two weeks. High-volume enrollment requires approximately one additional week to validate the final test submissions.
Am I required to report this adverse event? Email the MDR Policy Branch [email protected] with your question
How do I submit electronic reports other than MDRs to CDRH? Ex. eCopies or Radiation Emitting Product Email the CeSub Helpdesk at [email protected] and request information about the submission type in question
How do I submit electronic reports regarding drug adverse events? Email the CDER Electronic Submissions Helpdesk at [email protected] and request information about drug adverse event reporting
I received a letter informing me that a voluntary MedWatch report involving one of my firm's devices was received. Can I get the voluntary reporter's contact information in order to follow-up? The copy of the report that was sent provides all of the information that the FDA is allowed to release about the report in question. Please be aware that voluntary submitters can request that they not be identified to the device manufacturer. In either case, the copy of the report you received contains all of the releasable information.
How is the eMDR project related to the FDA ESG? All electronic submissions to the FDA use the ESG. You should purchase a digital certificate and register as a trading partner with the FDA. Once registered, you can submit electronic MDRs using the ESG. See more about ESG.
How will we know CDRH received our submission?

You will get three acknowledgments when you submit your MDR electronically.

Acknowledgment 1 (also referred to as Receipt) is sent by the ESG and confirms the submission was successfully received by the ESG. Below is an example of Acknowledgment 1.

This MDN (Message Disposition Notification) was automatically built on

Wed, 16 Feb 2022 17:56:54 GMT in response to a message with id

<2090565485.1.1645034213398@DRL0195254> received from

ZZFDATST on Wed, 16 Feb 2022 17:56:54 GMT.

Unless stated otherwise, the message to which this MDN applies
was successfully processed.

Acknowledgment 2 is sent by the ESG and indicates the submission reached CDRH. Below is an example of Acknowledgment 2.

MessageId: <2090565485.1.1645034213398@DRL0195254>

CoreId: ci1645034213939.35324@fdslv05768_te1

DateTime Receipt Generated: 02-16-2022, 12:57:57

"CDRH has received your submission"

Acknowledgment 3 is sent from CDRH and indicates your submission is successfully loaded or notifies you of any errors that occurred during validation and loading. Your "passed" Ack3 serves as proof that your submission was received and accepted by eMDR. Ack3 is provided in both HTML and XML format. For ACK3 examples both "passed" and "failed" please refer to  the implementation package: Health Level Seven (HL7) Individual Case Safety Reporting (ICSR) Files | FDA
What happens when Acknowledgment 3 notifies of errors in submissions? If you submit an electronic MDR and you get an error message in Acknowledgment 3, please correct the errors and resubmit the submission. When you resubmit the MDR, you will get another set of acknowledgments.
What is the time frame to receive these acknowledgments? You should receive your acknowledgments within 10 minutes after your submission unless ESG is down for maintenance.
Is there a recommended time of day to send submissions?

Submissions can be transmitted at any time using the ESG. The various systems used to process electronic MDRs are independent of each other with regard to scheduled maintenance and down-times:

The ESG is down: If the ESG is down, acknowledgments 1 and 2 will be delayed. Your submission will not reach CDRH for processing using the eMDR system. Refer to the Planned Maintenance and Status History | FDA for information on ESG maintenance and down-times.

eMDR system is down: If the eMDR system is down, acknowledgment 3 will be delayed. If the eMDR system is down, but the ESG is functional, your submission will be routed to CDRH, and you will receive acknowledgments 1 and 2. Refer to eMDR System Status | FDA for information on eMDR maintenance and down-times.
Are there any formatting requirements for filenames submitted using eMDR? Please make sure filenames do not contain periods except to indicate the file extension. Due to the way filenames are read, once a period is encountered, the rest of the filename is considered the file extension. For example, a filename such as "5555555555.5555.5555.xml" will be read as filename "5555555555.55555555xml." This will result in the FDA being unable to open and read the file properly, so please only include periods in a filename to indicate file extensions.
How do I submit a supplement/follow-up report?

Your supplement report will have the same report number, but it will be marked as a follow-up in G6 (for manufacturers) or F7 (for user facilities and importers). It will also include a follow-up number, which is 1 for the first supplement, and increments by 1 for each supplement thereafter. If you used eSubmitter to generate the initial report, you may reopen the submission in eSubmitter, update the relevant report fields, update G6/F7 with the appropriate follow-up information, and then repackage and resubmit your report. If you are starting from a blank report, be sure to include the report number from the initial report in the report number field.

Please do not repeat content in the narrative fields, because the supplement's narrative is appended to the original narrative in MAUDE. The values you include in other fields will be used to overwrite the corresponding value in the previous version of the report
Will requests for additional information from CDRH come to us electronically using the ESG? No, at this time the ESG is not set up to handle outgoing requests for additional information. You will receive any request for additional information by email.
Can I respond electronically to an FDA Request for Additional Information? Yes. Responses to FDA's Request for Additional Information can be reported electronically under MedWatch 3500A, Section H10. This includes all discrete data elements. Note that this is different from how supplemental reports are submitted (refer to question above). You may submit the letter you received as part of the attachment to the message.
What data can we use for testing? All test reports are loaded to the test MAUDE database. These reports will not be released to the public at any time. You can submit "made-up" data for testing or use data from a prior 3500A. To ensure that your report does not get rejected because a duplicate report is present in our system with the same report number, please use a leading 7 in your sequence number. Example -- CFN-YEAR-70001 or FEI/CMS-YEAR-70001.
How do I sign up to receive alerts about eMDR and other CDRH electronic submissions systems? You may use our Subscribe to CDRH Email Lists | FDA webpage and enter your email to subscribe to the subscription that best suits your needs.
Does the size of my submission matter? Delivery and processing time is dependent upon the overall size of your submission; larger submissions will take longer to be delivered and processed.
Who do we contact for questions regarding the FDA ESG? For questions regarding registration, setup, policy, andother FDA ESG quesitons, please write to [email protected]
Can we install FDA eSubmitter on a network? Yes. The software can be installed anywhere and will work properly. The file-locking option can be used to prevent users from accidentally overwriting the work of another. For details, see Networking in Preferences in the FDA eSubmitter User Manual.
We have a PDF we want to include. Can we add it to the zip file generated by FDA eSubmitter? No. Do not modify the file after it is generated by FDA eSubmitter. If you do, your submission will fail our loading process. Always attach the desired PDF to the appropriate question using the FDA eSubmitter software. Repackage your files and resubmit your submission to FDA.
Can we submit multiple patients or devices per MDR report? No. The current version of FDA eSubmitter allows only one patient and one device per MDR report; that is, each report may have only one Section A and one Section D.
How do we submit attachments? You can submit attachments electronically using the FDA eSubmitter application. Refer to the FDA eSubmitter User Manual.
How do we submit the adverse event information from the initial reporter, such as a User Facility (U/F) importer or voluntary reporter? Depending on the source of the initial report, you may submit the source report information as follows:
  • User facility or importer report – Include report information by populating the appropriate fields of the 3500A using FDA eSubmitter (i.e., populate all sections of the message pertaining to MedWatch 3500A Section F).
  • Voluntary report – Submit this as an attachment to your electronic MDR.
If you have more than one source report for the event—that is, both (1) and (2) as described above—include one report as part of your electronic MDR, and submit the other(s) as attachment(s).
How do we set up for testing with the eMDR system? eMDR utilizes the FDA Electronic Submissions Gateway (ESG), an agency-wide entry point for all electronic submissions, to receive electronic MDRs. The Gateway authenticates and validates electronic submissions and routes it to CDRH. After registering with the FDA Electronic Submissions Gateway as a trading partner, one of the requirements for an ESG production account is to submit a guidance complaint submission to CDRH. The purpose of testing is to catch any issues early on, so once you transition to electronic reporting, there are no major problems due to improper formatting or incorrect values in the submission. When you are ready to send a guidance compliant electronic MDR submission, please send the required test reports (based on your submission method) to the test ESG account.
How many reports are required for testing? Each method has its own unique submission process, testing requirements, and account enrollment process. Please follow the instructions located at How to Enroll in eMDR Program | FDA
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